Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
145465–145488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1986
TRACHEOSTOMY CARE KIT
K855130 · BTO
Dynarex Corp.
Anesthesiology · 71d
Cleared Mar 04, 1986
DYNA SYSTEM
K855167 · EGG
Parker Laboratories, Inc.
Dental · 68d
Cleared Mar 04, 1986
3M ARTHROSCOPIC SURGICAL SYSTEM
K855216 · HWE
3M Company
Orthopedic · 64d
Cleared Mar 04, 1986
SPIRAL-FLEX
K860105 · BTR
Sheridan Catheter Corp.
Anesthesiology · 50d
Cleared Mar 04, 1986
OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS
K860153 · JTN
Oxoid U.S.A., Inc.
Microbiology · 48d
Cleared Mar 04, 1986
INSTA KIT FOR GROUP A STREP ID
K860247 · GTZ
Mead Johnson & Co.
Microbiology · 39d
Cleared Mar 04, 1986
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES
K860296 · FKQ
Physicians Surgeons Purchasing Group
Gastroenterology & Urology · 35d
Cleared Mar 04, 1986
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES
K860297 · FKQ
Renal Hygienics
Gastroenterology & Urology · 35d
Cleared Mar 04, 1986
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
K860336 · FKQ
Breem Laboratories
Gastroenterology & Urology · 34d
Cleared Mar 04, 1986
MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
K860342 · JPA
Bio/Data Corp.
Hematology · 34d
Cleared Mar 04, 1986
DUAL LUMEN NEEDLE (PRODUCT CHANGE)
K860515 · LBW
Quinton, Inc.
Gastroenterology & Urology · 21d
Cleared Mar 04, 1986
ROTALEX
K860529 · LIQ
Orion Corp.
Microbiology · 21d
Cleared Mar 04, 1986
TBI NEEDLE
K860582 · GAA
Hobbs Medical, Inc.
General & Plastic Surgery · 14d
Cleared Mar 04, 1986
KULTSURE (CATALOGUE NO. M210)
K860656 · JSM
Ncs Diagnostics, Inc.
Microbiology · 11d
Cleared Mar 04, 1986
KULTSURE (CATALOGUE NO. M240)
K860657 · JSM
Ncs Diagnostics, Inc.
Microbiology · 11d
Cleared Mar 04, 1986
KULTSURE (CATALOGUE NO. M250)
K860658 · JSM
Ncs Diagnostics, Inc.
Microbiology · 11d
Cleared Mar 03, 1986
MDI QUIK TEST NARCOTICS DRUG SCREEN
K853140 · DNK
Medical Diagnostics, Ca.
Toxicology · 217d
Cleared Mar 03, 1986
AOT EXTERNAL COMPRESS DEVICE
K854241 · HWN
Advanced Ortho-Technology, Inc.
Orthopedic · 133d
Cleared Mar 03, 1986
LM2000A SURGICAL SUCTION MONITOR
K854359 · KDQ
Engineering, Inc.
General Hospital · 125d
Cleared Mar 03, 1986
ADHESIVE TAPE, WOUND CARE, WOUND DRESSING
K854463 · FRO
Avery Intl.
General & Plastic Surgery · 117d
Cleared Mar 03, 1986
IV SECUREMENT DEVICES
K854464 · FRO
Avery Intl.
General & Plastic Surgery · 117d
Cleared Mar 03, 1986
DETECTACULT
K854619 · KHE
Immunostics Co., Inc.
Microbiology · 105d
Cleared Mar 03, 1986
HEPANORM CALIBRATION PLASMA SET
K854762 · KFF
American Bioproducts Co.
Hematology · 96d
Cleared Mar 03, 1986
ACUSON L538 TRANSDUCER
K854787 · ITX
Acuson Computed Sonography
Radiology · 94d